BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 899334 · Received August 16, 2007

    Report

    Report Number
    2955842-2007-00263
    Event Type
    Other
    Date Received
    August 16, 2007
    Date of Event
    July 18, 2007
    Report Date
    August 17, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A MONITOR IN THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED HRSV. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE, AND THERE WAS NO INJURY TO THE PATIENT. AS OF AUGUST 15, 2007, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED NO VISION IN THE RIGHT MONITOR OF THE SYSTEM SURGEON CONSOLE. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention DA VINCI S SURGICAL SYSTEM INSTRUMENTS AND| ACCESSORIES